We will be at Pharmacy Expo 2026 taking place from May 5–7 in Warsaw, Poland. This pharmaceutical industry event brings together stakeholders from across the pharma, biotechnology, and healthcare sectors.
Expert Lectures by SciencePharma
Throughout the event, our experts will deliver three lectures covering key stages of the pharmaceutical product lifecycle from early development to market authorization and post-approval responsibilities.
Lecture 1: The Pathway from Drug Candidate to Obtaining Market Authorization – A Regulatory Roadmap
Speaker: Joanna Pawlak, PhD
Date: Day 1 – May 5 | 12:30–13:15
This session provides a practical overview of the EU drug development and regulatory pathway, from early-stage research to marketing authorization approval.
What will you learn:
- How to choose the right Marketing Authorisation pathway for your medicinal product
- How product type and formulation influence regulatory requirements
- How to plan studies efficiently and avoid unnecessary costs and delays
- How to increase the chances of a successful registration outcome
Lecture 2: Marketing Authorization Holder’s Responsibilities in the EU
Speaker: Joanna Popiołkiewicz, PharmD
Date: Day 2 – May 6 | 10:30–11:30
This lecture focuses on the role and responsibilities of the Marketing Authorization Holder (MAH) within the EU, with emphasis on managing a medicinal product after it has been granted marketing authorization.
What will you learn:
- The scope of MAH responsibilities across the full product lifecycle, from authorization to maintenance on the market
- Regulatory compliance obligations, including management of variations and post-authorization changes
- Requirements related to product quality and supply chain oversight (GMP and distribution control)
- How pharmacovigilance systems are implemented and adverse events are reported and monitored
- Responsibilities for maintaining and updating product documentation (SmPC, labeling, patient leaflets)
- How patient safety and ongoing market surveillance are ensured in practice
Lecture 3: Know the Market, Find the Partner – Market Analysis and Distributor Search for Medicinal Products
Speaker: Anna Bieńkowska, PhD
Date: Day 3 – May 7 | 12:00–12:45
Market analysis is a critical foundation for successful medicinal product launch and expansion, as it helps ensure decisions are based on real market conditions rather than assumptions. It enables a clear understanding of competitive environment, access barriers, and partnership opportunities, supporting more effective and lower-risk market entry strategies.
What will you learn:
- The session will explain which factors should be considered when analysing a market, from the presence of already registered products, through the competitive landscape and MAH strategies.
- We will talk on importance of analysis of competitive registered products, their Rx/OTC classification, reimbursement status, pricing and sales volumes, as well as risks such as parallel import and product shortages.
- Based on these insights the informed decisions on market entry can be made involving proper launch planning, portfolio expansion, and distribution partner selection.
Visit SciencePharma at Booth B1.41
We invite you to visit us at Booth B1.41 during the event. Our team will be available to discuss:
- Regulatory strategy and EU market authorization
Insights from Principal Consultants and Senior Team Leads in Regulatory Affairs, with deep expertise in nonclinical and clinical development.
- Nonclinical and clinical development support
Guidance from Heads and Deputy Heads of Nonclinical & Clinical, supporting efficient development planning and regulatory alignment.
- Operational regulatory affairs
Practical support from Senior and Operations Consultants in RA, including dossier preparation, submissions, and interactions with regulatory authorities.
Join SciencePharma in Warsaw and take part in Pharmacy Expo 2026!
Generate your free ticket to the trade fair here.